Study Finds HPV Vaccine Gardasil Safe

A new study of Merck & Co.'s Gardasil cervical-cancer vaccine showed it was associated with fainting on the day of inoculation and skin infections two weeks afterward, but no link with more serious health problems was found.

The vaccine protects against four strains of the human papillomavirus, or HPV, two of which account for about 70% of cervical-cancer cases in women. HPV is also linked to vaginal cancer in women and mouth and throat cancer in both men and women. The Centers for Disease Control and Prevention estimates about 15,000 women and 7,000 men are diagnosed with an HPV-related cancer each year in the U.S.

Fainting and skin problems such as redness and swelling at the injection site are known side effects of the vaccine. Doctors are instructed to have patients sit or lie down for 15 minutes after getting the shot.

The Gardasil study—led by the Kaiser Permanente Vaccine Study Center in Oakland, Calif.—was required by the U.S. Food and Drug Administration and the European Medicines Agency to provide an additional look at the vaccine's safety in a large group of people. It was funded by Merck.

Gardasil was first approved in 2006 for girls and women ages 9 to 26 years old before later being approved for use in males. GlaxoSmithKline PLC also sells an HPV vaccine, Cervarix, in the U.S. which was approved for use in females in 2009. Federal guidelines recommend that girls and boys ages 11 to 12 receive the HPV vaccine in a three-dose series before they are sexually active, and it coincides with recommendations on other vaccines given to that age group.

However, immunization rates lag that of other vaccines such as ones that protect against meningitis, partly because of concerns about the vaccine's safety, doctors say. The most recent CDC figures showed that 53% of girls ages 13 to 17 had received at least one dose of the HPV vaccine in 2011 but only 35% had completed the three-dose series, which are supposed to be given over six months.